Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls

NCT02735616 | Unknown

• 1 other identifier: 008215rmc
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals: 1\. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of heart rate along 3 days between patients after stroke in the sub-acute phase and control group matched by age and gender. 3. To describe the reaction and examine the differences in reactions of the heart autonomic system during rest, paced breathing and activity in both groups- stoke and control. The HRV will be monitored by Polar watch and the activity will be measured by accelerometer, both will be attached to the patients at the beginning of the trial and will stay on them for 3 whole days.

Conditions

Stroke

Keywords

heart rate variability; stroke

Outcome Measures

Primary Outcomes (2)

• heart rate variability

  Heart rate variability will be measured by Polar watch at the beginning of each day during the 3 days of the research. At the end of those days, the data will be collected and analyzed on computer software.

  3 days

• step counter

  Step counter by Polar loop. Stored in the device and transfer to a computer for analysis.

  three days follow up, (24-hours X 3)

Secondary Outcomes (4)

• Stroke activity Scale

  At admission

• Scandinavian Stroke Scale

  At admission

• Functional Independence Measure

  At admission

• Autonomic function questionnaire

  At admission

Study Arms (2)

study

15 CVA patients, 1-3 weeks after their first stroke. The patients will be hospitalized in the neurology department at the geriatric "Beit-Rivka" hospital at Petah-Tiva, Israel. patients with pacemaker or those who use Beta-Blocker drugs, as well as patients with cerebellar injury, will be excluded from the research

control

15 patients from the orthopedic department at the same hospital, matching by age and gender to the study group.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

15 CVA patients that are hospitalized in the neurology department at the geriatric "Beit-Rivka" hospital in Israel. The control group will be 15 patients from the orthopedic department of the hospital, matching by age and gender

You may qualify if:

• First stroke
• weeks after the stroke

You may not qualify if:

• Pacemaker
• Cardiac arrhythmia
• Use of Beta- Blocker drugs
• Cerebellar deficit
• Mini-Mental State Examination (MMSE) \< 18

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Avital Hershkovitz, MD

CONTACT

972-3-9373841; avitalhe@clalit.org.il

Ayelet Ronen, BPT

CONTACT

972-58-4070300; ayelet.rn@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Avital Hershkovitz

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 13, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share